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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05177900
Other study ID # s61020_IPG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date January 27, 2022

Study information

Verified date April 2022
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date January 27, 2022
Est. primary completion date January 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with essential tremor treated with Vim-DBS - Normal impedances of DBS circuit - Signed written informed consent Exclusion Criteria: - Active psychiatric disease or active alcohol or drug abuse - Dementia - History of recurrent or unprovoked seizures - Relevant comorbidities that influence objective clinical assessment - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Study Tool Computer
Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Myles Mc Laughlin

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic threshold (mA) Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA) During uptitration of the amplitude (entire process takes 3-4 minutes)
Primary Side effect threshold (mA) Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA) During uptitration of the amplitude (entire process takes 3-4 minutes)
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